IFB-088 observed to have a favorable safety, tolerability and pharmacokinetic profile in the Phase 1 trial
IFB-088 is advancing into a Multiple Ascending Dose part of the phase 1 trial to support a future Phase 2 trial in Charcot-Marie-Tooth disease
Nantes, France – May 15th, 2019. InFlectis BioScience SAS, a drug discovery company committed to the development of innovative therapeutics harnessing the Integrated Stress Response for the treatment of a broad range of diseases, today announced favorable results from the Single Ascending Dose (SAD) part of the Phase 1 trial (P188) that evaluated six single doses of IFB-088 administered by oral route. IFB-088, a selective inhibitor of stressed-induced PPP1R15A/PP1c phosphatase complex, is planned to be developed primarily for the treatment of Charcot-Marie-Tooth disease.
The SAD part of the double-blind, randomized, placebo-controlled Phase 1 trial evaluated the safety, tolerability and pharmacokinetics of six doses of IFB-088 in a total of 48 healthy volunteers. Results demonstrated IFB-088 to be well tolerated at doses ranging from 2.5 mg to 60 mg daily, with linear human pharmacokinetics over the dose range tested. IFB-088 was observed to show a favorable safety and tolerability profile with no serious adverse events at all doses tested within the trial.
Based on the favorable results of the SAD part, the Company is preparing to initiate the Multiple Ascending Dose (MAD) part of the Phase 1 study. The MAD will be conducted according to a double-blind, randomized, placebo-controlled, multi oral ascending dose design and will assess the safety, tolerability and pharmacokinetics of three doses of IFB-088 administered to healthy volunteers over 14 days.
Anne Visbecq, Chief Medical Officer of InFlectis BioScience SAS said: “We are pleased with the outcome of the IFB-088 SAD part of Phase 1 trial, which confirms the good tolerance profile of IFB-088. We are planning to initiate the MAD part in healthy volunteers during the summer of 2019 with completion expected in the fourth quarter. This trial will be important in the development plan of IFB-088 in Charcot-Marie-Tooth disease”.